- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of filgotinib.
Moderate to severe active rheumatoid arthritis-other regimens unsuitable
Treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Filgotinib can be used as monotherapy or in combination with methotrexate.
200mg once daily.
Patients aged 75 years and over: 100mg once daily. The dose may be increased to 200mg once daily if the particular clinical circumstance of the patient has been considered.
Patients with Renal Impairment
Creatinine clearance 15 to less than 60ml/minute: 100mg once daily.
Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 18 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L at baseline
Renal impairment - creatinine clearance below 15ml/minute
Severe hepatic impairment
Precautions and Warnings
Females of childbearing potential
History of recurrent infection
Patients over 75 years
Predisposition to infection
Predisposition to venous thromboembolism
Glucose-galactose malabsorption syndrome
History of tuberculosis
History of venous thromboembolism
Moderate renal impairment
Administration of live vaccines is not recommended
Before initiating screen all patients for viral hepatitis
Interrupt therapy if herpes zoster occurs
Advise patient dizziness may affect ability to drive or operate machinery
Avoid concurrent use of immunosuppressants
Before starting therapy ensure immunisations are up to date
Monitor patients for non-melanoma skin cancer prior to and during treatment
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Monitor for and manage hepatitis reactivation during treatment
Monitor patient for signs of serious infection
Monitor serum lipids 3 months after initiation
Monitor serum lipids in patients with hyperlipidaemia
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Immunosuppressive drugs may increase risk of malignancy
Interrupt if haemoglobin falls below 8 g/dL
Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt treatment if severe infection develops
Discontinue if symptoms of deep vein thrombosis occur
Discontinue if symptoms of pulmonary embolism occur
Male: May cause infertility
Female: Contraception required during and for 1 week after treatment
Pregnancy and Lactation
Filgotinib is contraindicated during pregnancy.
The manufacturer advises that filgotinib may cause foetal harm and should not be used during pregnancy. Animal studies have shown reproductive toxicity.
Filgotinib is contraindicated during breastfeeding.
The manufacturer advises that filgotinib should not be used during breastfeeding as it is unknown whether it is excreted in human milk. A risk to newborns/infants cannot be excluded.
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Upper respiratory tract infection
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2022
Summary of Product Characteristics: Jyseleca 100mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.
Summary of Product Characteristic: Jyseleca 200mg film-coated tablets. Gilead Sciences Ltd. Revised December 2021.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.